Colonoscopic Probiotics Infusion for Functional Gastrointestinal Disease
Status:
Not yet recruiting
Trial end date:
2022-11-01
Target enrollment:
Participant gender:
Summary
The purpose of this project is to study the the efficacy and safety of probiotics
implantation through infusion during colonoscopy in the treatment of functional constipation
and irritable bowel syndrome. The study is a single-center, prospective, randomized,
single-blind, controlled, cohort study. The invesitigators plan to enroll 80 patients with
functional constipation and 80 patients with irritable bowel syndrome. The invesitigators
will randomize the included study subjects. The experimental group receive basic treatment
and a single infusion of probiotics through colonoscopy. The control group receive basic
treatment and a single injection of normal saline through colonoscopy. The invesitigators
will follow up the patients for 8-12 weeks. The primary endpoint is the efficacy of the
single colonoscopic probiotics infusion in functional constipation and irritable bowel
syndrome patients. The secondary endpoint is the safety of the single colonoscopic probiotics
infusion in functional constipation and irritable bowel syndrome patients. Other exploratory
objectives include the alterations in clinical indicators, fecal microbiota, and intestinal
microbiota metabolites in feces and serum.
Phase:
Phase 4
Details
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University